The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes manufactured by International Technidyne Corporation.The affected lot numbers are E3JCC013-P1 and E3JCC014-P2 and the expiration date is May 2014.
The manufacturer has determined that Citrate APTT cuvettes from the lots listed above may recover higher than expected results in normal individuals. The manufacturer's investigation into the affected lots identified that when performing tests on non-heparinized e.g., normal blood samples, results may average higher than historic values. Test results performed on patients receiving heparin therapy are not affected.
The manufacturer has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated APTT baseline may contribute to serious injury.
Customers are requested to inspect their stock and quarantine all affected lots of the product, which will be arranged for recovery and replacement. Customers are also advised to discuss with the Laboratory Director about the requirement for retesting of reported patient results.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01364-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 January 2014